Laserfiche WebLink
EXHIBIT B <br />COMPETENCIES <br />Title of Training: Regulatory Affairs and Compliance <br />Training Provider Name: UCI Division of Continuing Education <br />Training Length: 150 Hours 47 Weeks <br />*Listed below are skills, knowledge, and abilities a student will have obtained <br />upon completion of training; completion of training is based on the overall <br />completion of coursework. (Completion of coursework: overall score of at least 73%.l <br />"Student will be able to: <br />Competency Measurement <br />Gain knowledge on the product development process and <br />Coursework <br />1 <br />product lifecycle for pharmaceuticals and medical devices <br />Learn how to maintain regulatory compliance across the <br />Coursework <br />2 product lifecycle <br />3. Effectively utilizing key databases and resources to gather <br />Coursework <br />critical information relevant to regulatory affairs <br />Understand FDA and regulatory agencies in terms of <br />Coursework <br />4 structure, regulations, and enforcement <br />5 Learn requirements and approaches to create and maintain <br />Coursework <br />compliance with quality systems <br />6 Earn professional development credits to maintain your <br />Coursework <br />RAC credential with RAPS <br />7. Establish an educational pathway for advanced education <br />Coursework <br />in FDA regulations, compliance, and policy <br />8. <br />9. <br />10. <br />11. <br />12. <br />13, <br />14. <br />Revised October I, 2016 <br />Minimum Score <br />73% <br />73% <br />73% <br />73% <br />73% <br />73% <br />